Senior Quality Assurance Associate - 2nd Shift

Posté 20 oct. 2021

Madison, Wisconsin - United States

Demander un identifiant 232049


A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


Your Role:


The Senior Quality Assurance Associate at MilliporeSigma in Madison, WI is a critical member of our Quality Assurance Operations (QAO) team. The QAO function is present or easily accessible to operations in the Manufacturing facility to support data integrity, root cause analysis, data and batch review, document control and auditing. With a partnership approach the QAO provides guidance and coaching during operations, as well as to assesses and audits manufacturing processes in real time, giving immediate review and constructive (perhaps instructive) feedback. The ALCOA+ attributes are reinforced by having QA staff on the manufacturing floor. This position is on 2nd shift with regular scheduled hours of 1pm-11pm Monday-Thursday.


Batch review and release

  • Preparation of documentation for production execution including batch records, supplemental logs, packaging and shipping and other documents in support of cGMP operations
  • Presence in Production/QC and warehouse areas to review documentation whether paper or electronic, perform line clearances and perform QA checks
  • Review batch records in a timely manner to meet committed release dates and ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate
  • Prepare certificates of analysis and batch release documentation for accuracy and completion prior to final release of product
  • Product release through the review of batch documentation
  • Owners of the RFT metrics and QAO KPIs   

Internal Audits and Self-inspection

  • Conducts internal audits and self-inspection for the Madison/Verona site
  • Conducts data integrity (DI) training and DI audits
  • Support the DI assessment program


Who You Are: 


Minimum Qualifications:      


  • Bachelor’s degree in Biology, Chemistry, Chemical Engineering, or related life science discipline
  • 1+ years’ experience in Quality Assurance, Quality Control, or a related area in a GMP environment


Preferred Qualifications:


  • Basic knowledge of FDA regulations (21 CFR Parts 11, 210, 211 etc.)
  • Experience in Quality Assurance or related field within a GMP environment
  • Familiarity with International regulations (EMA, MHRA)
  • Strong communication (oral and written) and interpersonal skills
  • Acts ethically and ensures quality of own work and that of others
  • Takes responsibility for ensuring that turnaround times are met
  • Works with cross-functional teams and builds networks within QA Operations and other departments
  • Open-minded, flexible, and works with agility 

RSRMS MilliporeSigma Millipore Sigma

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Our Benefits -

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The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.